An FDA intercenter coordinating group will oversee medical product advertising to ensure it is properly regulated, according to Acting Commissioner Lester Crawford, PhD/DVM.

The new group will work to "rationalize FDA policy and procedures, coordinate enforcement methods and establish a unitary means of communicating with the public." Crawford highlighted the issue in a speech to the National Press Club Aug. 2 in Washington, D.C.

The acting commissioner listed outdoor advertising, comparative claims and implied claims as areas of promotion that have been "of concern." He noted that FDA would provide clarity on these issues through new guidance "in the months ahead."

In February, FDA released three direct-to-consumer advertising draft guidances for drugs and devices (¹ Also see "Device DTC Guidances Aim To Hone Enforcement, Stimulate Patient Education" - Medtech Insight, 9 February, 2004., p. 6).

FDA's drug center division that regulates advertising (DDMAC) may receive a windfall of $500,000 in fiscal 2005 to monitor promotional activity. A House amendment to the FDA appropriations bill aims to divert that amount from the Office of the Chief Counsel.

The amendment's sponsor, Rep. Maurice Hinchey (D-N.Y.) faults Chief Counsel Daniel Troy for intervening in ongoing tort cases on behalf of several drug companies and device maker Pacesetter (² Also see "FDA Approps Amendment Targets Chief Counsel Troy" - Medtech Insight, 19 July, 2004., p. 4).

At the NPC event, Crawford defended FDA's role in product liability suits, maintaining that patients' rights are "not at issue." He stressed that the agency's actions were not unique and that "this FDA is certainly as sensitive as any I've been privileged of working in."

However, "FDA needs to be the final authority on the approvals that we put forth," Crawford emphasized, adding that the agency "will do what we can do to maintain preeminence and priority in this area."

Manufacturers should not have to defend their product approvals in state courts, he remarked. "It is wrong and severely damaging to public health in the U.S. if a company has to...fight 50 state court battles to sustain approval."

Crawford Announces New Ad Policy Group, Defends FDA Court Interventions

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